Manager - QA Investigation and CAPA
Core
Manager responsible for quality oversight, approval of deviation assessments, investigations, and CAPA records at a cell therapy manufacturing facility.
Role type
Manager, Quality Assurance (QA) Investigations
Builds
Quality assurance of manufactured cell therapy products in compliance with regulations
Domain
Biopharmaceuticals / Cell Therapy Manufacturing
Required skills
Root cause analysis, CAPA management, regulatory guideline interpretation, technical report authoring, risk assessment, cross-functional collaboration, team coaching, strategic thinking
Preferred skills
FDA/EMA regulations knowledge, electronic system proficiency, continuous improvement project leadership
Technologies
MS Office, Smartsheets, Ishikawa Diagram, 5-WHY, Process Flow Diagram
Responsibilities
Review and approve complex investigations/CAPAs/effectiveness checks; Author and review technical reports and risk assessments; Coach employees on deviation processes; Resolve investigational process issues; Liaise with global teams; Support internal and external inspections; Drive continuous improvement goals
Seniority
Manager, people management and IC capability